Excellent opportunity for a Site Microbiologist to join a global biologics company in the west of Ireland. Reporting to the QC Manager, this key role oversees the upgrade of cleanrooms from Grade D to Grade A, ensuring regulatory compliance. The Site Microbiologist also manages classification of all non-Grade A areas. A strong self-starter with expert knowledge of microbiology and biopharmaceutical GMP is essential.
Overview of your responsibilities:
* Lead cleanroom upgrades from Grade D to Grade A.
* Develop action plans covering timelines, resources, costs, and risks.
* Ensure GMP and regulatory compliance.
* Conduct audits to maintain cleanliness and sterility.
* Implement environmental monitoring for upgraded cleanrooms.
* Analyse data and address issues.
* Lead aseptic process simulation (APS) qualifications.
* Develop APS validation protocols and reports.
* Experience in equipment, HVAC, and critical system validation in GMP.
Knowledge, Skills and Experience Required for the Role:
* 5+ years' experience, ideally in biopharmaceuticals (Grade A cleanroom/aseptic processing preferred).
* Extensive cleanroom validation and qualification experience.
* Proven management of environmental monitoring programs.
* Cleanroom upgrade experience desirable.
* Experience with regulatory and client inspections/audits.
For a confidential discussion and more information on the role, contact Courtney Russell at courtney.russell@collinsmcnicholas.ie or call +353 (0) 71 9108062.
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